Trials Sponsors Conditions Drugs Pricing

Conditions

Cancer Insomnia

Keywords

cancerauricular pressure beanselectroacupunctureinsomniaestazolam

Outcome Measures

Primary Outcomes (1)

The Insomnia Severity Index(ISI)
The scale is a simple tool used for screening insomnia, consisting of 7 items designed to assess the nature and symptoms of sleep disturbances in the subjects.
Data will be collected at the end of the 0th, 4th, and 8th weeks of treatment and during follow-up (12th, 16th, and 20th weeks).

Secondary Outcomes (3)

Pittsburgh Sleep Quality Index(PSQI)
Data will be collected at the end of the 0th, 4th, and 8th weeks of treatment and during follow-up (12th, 16th, and 20th weeks).
Hamilton Anxiety Scale(HAMA)
Data will be collected at the end of the 0th, 4th, and 8th weeks of treatment and during follow-up (12th, 16th, and 20th weeks).
Hamilton Depression Rating Scale(HAMD)
Data will be collected at the end of the 0th, 4th, and 8th weeks of treatment and during follow-up (12th, 16th, and 20th weeks).

Study Arms (2)

Arm I (ONS group)

EXPERIMENTAL

Patients will receive estazolam with auricular pressure points and electroacupuncture treatment. Interventions:In the experimental group, estazolam (oral estazolam 1-2 mg daily at bedtime) was combined with auricular pressure point therapy and electroacupuncture over an 8-week period.

Drug: estazolam 1-2 mgProcedure: Auricular pressure bean combined with electroacupuncture

Arm II (NS group)

ACTIVE COMPARATOR

Patients will follow the standard estazolam treatment program(oral estazolam 1-2 mg daily at bedtime for 8 weeks).

Drug: estazolam 1-2 mg

Interventions

estazolam 1-2 mgDrug

oral estazolam 1-2 mg daily at bedtime for 8 weeks.

Arm I (ONS group)Arm II (NS group)

Auricular pressure bean combined with electroacupunctureProcedure

Electroacupuncture treatment will be performed on seven acupoints, including Baihui (GV20), Shenting (GV24), Yintang (GV29), Anmian (EX-HN22), Shenmen (HT7), Neiguan (PC6), and Sanyinjiao (SP6). Each session lasts for 30 minutes and is conducted twice a week.In addition, auricular point seed-pressing therapy will be applied to bilateral auricular points related to insomnia (Shenmen, Heart, and Sympathetic). Each auricular point will be pressed for 1 minute, three times a day. The total treatment course is eight weeks.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age 18 and above.
The diagnosis of a malignant solid tumor was confirmed by pathological examination.

Sponsors & Collaborators

Qinghai Red Cross Hospital
Otherlead

Study Sites (1)

China, Qinghai,Qinghai Red Cross Hospital

Xining, Qinghai, 810000, China

RECRUITING

Qiuxia Dong DrCONTACT2816278916@qq.com

MeSH Terms

Conditions

NeoplasmsSleep Initiation and Maintenance Disorders

Interventions

EstazolamElectroacupuncture

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 27, 2025

First Posted

March 5, 2025

Study Start

March 1, 2025

Actual (reported)

Primary Completion

March 1, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Efficacy of Auricular Pressure Beans with Electroacupuncture and Estazolam Treating Insomnia Caused by Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Arm I (ONS group)

Arm II (NS group)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Arm I (ONS group)

Arm II (NS group)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations